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ZL01-060225 Quality - Cleaning & Support Technician

ZL01-060225 Quality - Cleaning & Support Technician

Validation & Engineering Group, IncManati, 091
Hace más de 30 días
Descripción del trabajo

Department : Field - BE Location : Manati, 091

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Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position :

  • Quality - Cleaning & Support Technician

MAJOR DUTIES AND RESPONSIBILITIES :

1. Perform daily operation cleaning, sanitization and decontamination of the Parenteral Manufacturing Areas and equipment :

  • Cleans and sanitizes sterilize manufacturing area rooms and equipment.
  • Documents the cleaning process following the good documentation practices.
  • Sterilizes equipment to be used in the cleaning process by operating an autoclave.
  • Prepares germicide and sporocidal solutions as per SOP.
  • Filtrates isopropyl alcohol 70%, when necessary.
  • Maintains inventory and request all necessary components and operating materials in order to assure continue operations.
  • Completes preparation of cleaning equipment used for production activities.
  • Maintains good communication with support departments in order to comply with all the manufacturing needs.
  • Performs fogging process with sporocidal solutions through the Air handling Unit ducts.
  • Checks and verifies manufacturing equipment, installation, calibration, and connections.
  • Tests the filter bubble point before and after the IPA filtration process.
  • Cleans and unloads the autoclave every week.
  • Completes all required production documentation in a legible, error free and on time manner following good documentation practices.
  • Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
  • Coordinates, checks and verifies all manufacturing equipment installation, calibration and connections.

    • 2. Performs duties related to support other areas as required by the supervisor

  • Attends and actively participate in meetings and trainings for department communication, safety, security, and quality.
  • Participates in production scheduling meeting.
  • Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to the supervisor.
  • Assists other areas within operations and at the site.

    • 3. Performs Environmental Health and Safety duties required by the job as follow

  • Maintains housekeeping within controls and aseptic environments, according to procedures.
  • Handles Hazardous and Non hazardous waste according to EHS procedures.
  • Supports Environmental Monitoring Program by assuring sampling collection within manufacturing area on established timeframe.
  • Supports Annual Requalification Program by assuring plan execution on established timeframe.
  • Maintains the reusable garment program inventory control.

    • KNOWLEDGE / EDUCATION / EXPERIENCE :

  • High School Diploma
  • One (1) year experience in Parenteral or manufacturing processes Knowledge of Aseptic Processing Technical skills.
  • Understanding of basic science concepts as applicable to the process / product and their impact in product quality.
  • Proficiency using computer, software, and / or automated equipment as related to assigned functions.
  • Willing to learn new Computerized, PLC control equipment, procedures and new scientific processes.
  • Ability to collect numerical data and skill in basic mathematical applications (basic calculations such as additions, subtractions, multiplication, division, rounding, average and yields)
  • Ability to maintain housekeeping and handles waste according to procedures.
  • Ability to maintain daily production and labor data in computerized system.
  • Ability to follows the daily production schedules.
  • Basic knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization preferable.
  • Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
  • Ability to work with minimum supervision, take decisions to resolve day-to-day problems in accordance with regulations and internal procedures.
  • Ability to communicate via multiple channels and with varied audiences ( team members, FDA, EMEA, OSHA, senior leaders).
  • Ability to read procedures and documents in English / Spanish Text (e.g. SOPs, Batch Records, etc.)
  • Ability to operate pharmaceutical manufacturing equipment.
  • Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
  • Knowledge of the basic theory supporting environmental monitoring and in process test and impact of results in product quality.
  • Understand the impact of temperature, humidity and pressure control and monitoring within an aseptic area. Has knowledge of room classification criteria and specific room’s classification.
  • Strong organizational skills.
  • Able to wear sterile gowns, full face mask, and full face respirators where required, use Latex / Nitrile Gloves and disposable uniforms.
  • Able to move objects such as lifting, carrying, pushing and pulling (25-60 pounds).
  • Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
  • Ability to operate pallet jacks.

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    Cleaning • Manati, 091